Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)

This study has been completed.

Study NCT00424008 Information provided by Schering-Plough

First Received on January 17, 2007. Last Updated on December 17, 2010 History of Changes

Results First Received: June 30, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: Mometasone furoate/formoterol (MF/F) MDI Drug: Fluticasone propionate/salmeterol (F/SC) DPI

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In order to standardize treatment prior to randomization, participants entered a 2- to 4-week open-label Run-in period where they received MF MDI 200 mcg BID. Participants who continued to meet eligibility criteria at the completion of the Run-in Period were randomized into the study.

Reporting Groups

	Description
MF/F MDI 200/10 Mcg BID	Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
F/SC DPI 250/50 Mcg BID	Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID

Participant Flow: Overall Study

	MF/F MDI 200/10 Mcg BID	F/SC DPI 250/50 Mcg BID
STARTED	371	351
COMPLETED	22	16
NOT COMPLETED	349	335
Adverse Event	8	6
Lack of Efficacy	40	34
Lost to Follow-up	1	2
Withdrawal by Subject	5	8
Noncompliance with protocol	13	7
Did not meet protocol eligibility	16	21
Administrative	266	257

Baseline Characteristics

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Reporting Groups

	Description
MF/F MDI 200/10 Mcg BID	Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
F/SC DPI 250/50 Mcg BID	Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID

Baseline Measures

	MF/F MDI 200/10 Mcg BID	F/SC DPI 250/50 Mcg BID	Total
Number of Participants [units: participants]	371	351	722
Age, Customized [units: participants]
12 to <18 years	22	18	40
18 to <65 years	321	308	629
>=65 years	28	25	53
Gender [units: participants]
Female	239	220	459
Male	132	131	263

Outcome Measures

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1. Primary:

The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline to Week 12 ]

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2. Secondary:

Onset-of-action Based on Change From Baseline FEV1 at the 5 Min Pulmonary Function Test (PFT) Assessment on Day 1 [ Time Frame: Baseline to 5 minutes post-dose on Day 1 ]

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3. Secondary:

Change From Baseline in Asthma Control Questionnaire (ACQ) Total Score at Week 12 Endpoint [ Time Frame: Baseline to Week 12 ]

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4. Secondary:

The Proportion of Symptom-free Days and Nights (Combined) Over the 12-week Treatment Period. [ Time Frame: Baseline to Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The investigator agrees not to publish/present any interim results without prior sponsor written consent. The investigator agrees to provide to the sponsor, 45 days prior to submission, review copies for publication that report any study results. The sponsor has the right to review and comment. If the parties disagree, investigator agrees to meet with the sponsor, prior to submission for publication, to discuss and resolve any such issues/disagreement.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The sponsor closed the study early, at 12 weeks treatment, for reasons that were not safety related. No efficacy analysis of data collected beyond 12 weeks of treatment was performed. All safety data were examined regardless of treatment duration.

Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00424008 History of Changes
Other Study ID Numbers:	P04705, SCH 418131
Study First Received:	January 17, 2007
Results First Received:	June 30, 2010
Last Updated:	December 17, 2010
Health Authority:	United States: Food and Drug Administration